A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects

Overseen By Kevin Hsiao

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Lumosa Therapeutics Co., Ltd.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Alcohol use, Coagulation abnormality, others

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it is designed to study drug interactions, so you might need to discuss your medications with the trial team.

How is the LT3001 drug different from other treatments?

The LT3001 drug product is unique because it uses solid lipid nanoparticles (SLN) for drug delivery, which can enhance the solubility and bioavailability of poorly water-soluble drugs, potentially improving therapeutic efficacy. This method allows for targeted delivery and controlled release, which may not be available with standard treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests a new drug, LT3001, in healthy people to see if it's safe and how it behaves in the body. It also checks if LT3001 interacts with common medications like aspirin and blood thinners.

Research Team

Mimi Yeh, PhD

Principal Investigator

Lumosa Phase 1 unit

Eligibility Criteria

Inclusion Criteria

Subject's body weight is ≥50 kg and BMI is within the range of 18 to 32

Subject is a healthy volunteer.

Subject's PT, aPTT, and TT are within the normal laboratory range.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Double-blind, placebo-controlled phase to examine the safety and PK profiles of multiple doses of LT3001

10 days

Multiple visits (in-person)

Treatment Part B

Open-label phase to assess the safety and PK of LT3001 when coadministered with aspirin, clopidogrel, apixaban, or dabigatran

8-16 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LT3001 drug product

Participant Groups

Group I: Part B - LT3001 and Dabigatran Experimental Treatment 2 Interventions

Multiple doses of LT3001 and Dabigatran administered

Group II: Part B - LT3001 and Clopidogrel Experimental Treatment 2 Interventions

Multiple doses of LT3001 and Clopidogrel administered

Group III: Part B - LT3001 and Aspirin Experimental Treatment 2 Interventions

Multiple doses of LT3001 and Aspirin administered

Group IV: Part B - LT3001 and Apixaban Experimental Treatment 2 Interventions

Multiple doses of LT3001 and Apixaban administered

Group V: Part A - LT3001 Drug Product Experimental Treatment 1 Intervention

Multiple doses of LT3001 administered by intravenous infusion

Group VI: Part A - Placebo Placebo Group 1 Intervention

Multiple doses of Placebo administered by intravenous infusion

Who Is Running the Clinical Trial?

Lumosa Therapeutics Co., Ltd.

Lead Sponsor

Trials

8

Recruited

690+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of different parameters on reconstitution of lyophilized SLN. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Development and characterization of a cationic lipid nanocarrier as non-viral vector for gene therapy. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Preparation and characterization of solid lipid nanoparticles containing cloricromene. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Solid lipid microparticles: formulation, preparation, characterisation, drug release and applications. [2009]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Design Optimization and Evaluation of Solid Lipid Nanoparticles of Azelnidipine for the treatment of Hypertension. [2022]